Growth Hormone DeficiencyMETAB-BELGROWNCT07173036
Evaluation of (Cardio)Metabolic and Auxological Outcomes of GHD Patients Under rhGH or LAGH With Stratification According to IGF-1 Levels
A study testing metabolic and auxological outcomes in people with Growth Hormone Deficiency, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain.
Trial summary
The METAB-BELGROW-LAGH study aims to prospectively evaluate the metabolic outcomes of Belgian children diagnosed with growth hormone deficiency (GHD) over a three-year period following the initiation of treatment with either daily recombinant human growth hormone (rhGH) or weekly long-acting growth hormone (LAGH). Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Growth Hormone Deficiency
- What is being tested?
- metabolic and auxological outcomes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2026to 1 Sep 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Diagnosed with growth hormone deficiency (GHD)
- Treated with growth hormone (rhGH or LAGH)
Who cannot join
- No exclusion criteria
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Micheline Grillet, PhD contact
About this study
Official title: Evaluation of (Cardio)Metabolic and Auxological Outcomes of GHD Patients Under Recombinant Human or Long-acting Growth Hormone With Stratification According to IGF-1 Levels
The METAB-BELGROW-LAGH study aims to prospectively evaluate the metabolic outcomes of Belgian children diagnosed with growth hormone deficiency (GHD) over a three-year period following the initiation of treatment with either daily recombinant human growth hormone (rhGH) or weekly long-acting growth hormone (LAGH). Patients will be stratified according to their IGF-1 levels. The primary objective is to assess the metabolic outcomes of children treated with daily rhGH over the first three years. The secondary objectives include comparing the metabolic outcomes between patients treated with daily rhGH and those treated with weekly LAGH, and characterizing metabolic profiles based on IGF-1 levels. To achieve these objectives, both standard-of-care (SOC) and additional data will be collected at scheduled follow-up visits (baseline, 6, 12, 24, and 36 months), including clinical, auxological, and biological parameters. Additional metabolic markers, inflammatory and endothelial biomarkers will be assessed. In a subset of patients, carotid intima-media thickness (cIMT) and body fat distribution (via DEXA-scan) will also be measured.
- Conditions
- Growth Hormone Deficiency
- Being tested
- metabolic and auxological outcomes
- Keywords
- metabolic outcomes, auxological outcomes, recombinant human growth hormone, long acting growth hormone
- Medical subject headings
- Dwarfism, Pituitary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
metabolic and auxological outcomesOther
Evaluation over a three-year period following the initiation of treatment with daily recombinant human growth hormone (rhGH)
metabolic and auxological outcomesOther
Evaluation over a three-year period following the initiation of treatment with weekly long-acting growth hormone (LAGH).
| Study group | Role | What they receive |
|---|---|---|
| rhGH cohort | Other | Patients with GHD who receive daily rhGH (dose titration according to guidelines i.e. 25-35 micrograms/kg body weight/day) Receives: Other: metabolic and auxological outcomes |
| LAGH cohort | Other | Patients with GHD who receive weekly LAGH (dose titration according to guidelines i.e. for somatrogon 0.66 milligrams/kg body weight/week) Receives: Other: metabolic and auxological outcomes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Auxological evaluation_1
Primary outcome measures included change in stature (in cm and SDS) over the course of the study.
Measured: 3 years
Auxological evaluation_2
Primary outcome measures included change in weight (in kgs and SDS) over the course of the study.
Measured: 3 years
Auxological evaluation_3
Primary outcome measures included change in BMI (in kg/m2) over the course of the study.
Measured: 3 years
Evaluation of the blood pressure
Measure of the systolic and diastolic blood pressure (in mmHg) with a sphygmomanometer
Measured: 3 years
Evaluation of waist circumference
Measure of waist circumference (in cm) with a meter
Measured: 3 years
Evaluation of clinical signs of puberty (Tanner stage) and androgenism
Evaluation of clinical signs of puberty (Tanner stage) and androgenism.
Measured: 3 years
Metabolic evaluation_1
Evaluation of the change of the metabolic profile using both SOC and non-SOC Blood tests samples. Measurements of fasting glycemia (mg/dl).
Measured: 3 years
Metabolic evaluation_2
Evaluation of the change of the metabolic profile using both SOC and non-SOC Blood tests samples. Measurements of fasting insulin (pmol/L).
Measured: 3 years
Metabolic evaluation_3
Evaluation of the change of the metabolic profile using both SOC and non-SOC Blood tests samples. Measurements of hemoglobin A1c in diabetic patients (%).
Measured: 3 years
Metabolic evaluation_4
Evaluation of the change of the metabolic profile using both SOC and non-SOC Blood tests samples. Measurements of transaminases (UI/L).
Measured: 3 years
Metabolic evaluation_5
Evaluation of the change of the metabolic profile using both SOC and non-SOC Blood tests samples. Measurements of lipid profile (mg/dL).
Measured: 3 years
Metabolic evaluation_6
Evaluation of the change of the metabolic profile using both SOC and non-SOC Blood tests samples. Measurements of creatinine (mg/dL).
Measured: 3 years
Metabolic evaluation_7
Evaluation of the change of the metabolic profile using both SOC and non-SOC Blood tests samples. Measurements of alkaline phosphatase (UI/L).
Measured: 3 years
Metabolic evaluation_8
Evaluation of the change of the metabolic profile using both SOC and non-SOC Blood tests samples. Measurements of calcium (mmol/L).
Measured: 3 years
Metabolic evaluation_9
Evaluation of the change of the metabolic profile using both SOC and non-SOC Blood tests samples. Measurements of phosphorus (mmol/L).
Measured: 3 years
Metabolic evaluation_10
Evaluation of the change of the metabolic profile using both SOC and non-SOC Blood tests samples. Measurements of insulin-like growth factor 1 levels (ng/mL).
Measured: 3 years
Bone markers_1
Measurements in blood samples of bone markers such as procollagen type 1 N-terminal propeptide (µg/L).
Measured: 3 years
Bone markers_2
Measurements in blood samples of bone markers such as insulin-like growth factor (ng/mL).
Measured: 3 years
Bone markers_3
Measurements in blood samples of bone markers such as insulin-like growth factor binding protein (µL/mL).
Measured: 3 years
Endothelial stress and inflammatory markers_1
Measurements in blood samples of endothelial stress and inflammatory markers such as asymmetric dimethylarginine (µmol/L).
Measured: 3 years
Endothelial stress and inflammatory markers_2
Measurements in blood samples of endothelial stress and inflammatory markers such as TNF-a (pg/mL).
Measured: 3 years
Endothelial stress and inflammatory markers_3
Measurements in blood samples of endothelial stress and inflammatory markers such as VEGF (pg/mL).
Measured: 3 years
Endothelial stress and inflammatory markers_4
Measurements in blood samples of endothelial stress and inflammatory markers such as IL-6 (pg/mL).
Measured: 3 years
Radiological evaluation of cIMT
Measurements of cIMT (mm) using Doppler ultrasound.
Measured: 3 years
Radiological evaluation of body fat distribution
Measurements of body fat distribution (g/cm2) using DEXA-Scan.
Measured: 3 years
Secondary outcomes (2)
comparison with patients under weekly LAGH
Data obtained for patients with daily rhGH will be compared to data obtained for patients with weekly LAGH treatment.
Same measurement description as for the primary outcomes.
Measured: 3 years
Stratification of the metabolic profile of the patients according to IGF-1 levels
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2025
- Study start1 Jul 2026 (estimated)
- Primary completion1 Sep 2031 (estimated)
- Study completion1 Sep 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Growth Hormone DeficiencyStudies of the same condition, open and under way.
- More trials run by Cliniques universitaires Saint-Luc- Université Catholique de LouvainThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be classified into two groups (depending on their treatment as decided by their pediatric endocrinologist): * patients with GHD who receive daily rhGH= rhGH cohort * patients with GHD who receive weekly LAGH= LAGH cohort
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe Lysy, MD, PhD, Principal investigator, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07173036
- Sponsor's protocol ID
- 2025/02JUI/216
- Acronym
- METAB-BELGROW
- Status last verified
- May 2026
- First submitted
- 13 Jun 2025
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of (Cardio)Metabolic and Auxological Outcomes of GHD Patients Under Recombinant Human or Long-acting Growth Hormone With Stratification According to IGF-1 Levels
- ClinicalTrials.gov ID
- NCT07173036
- Acronym / sponsor ID
- METAB-BELGROW / 2025/02JUI/216
- Conditions
- Growth Hormone Deficiency
- Keywords
- metabolic outcomes, auxological outcomes, recombinant human growth hormone, long acting growth hormone
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 1 Sep 2031 (estimated)
- Study completion
- 1 Sep 2031 (estimated)
- First posted
- 15 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The METAB-BELGROW-LAGH study aims to prospectively evaluate the metabolic outcomes of Belgian children diagnosed with growth hormone deficiency (GHD) over a three-year period following the initiation of treatment with either daily recombinant human growth hormone (rhGH) or weekly long-acting growth hormone (LAGH). Patients will be stratified according to their IGF-1 levels. The primary objective is to assess the metabolic outcomes of children treated with daily rhGH over the first three years. The secondary objectives include comparing the metabolic outcomes between patients treated with daily rhGH and those treated with weekly LAGH, and characterizing metabolic profiles based on IGF-1 levels. To achieve these objectives, both standard-of-care (SOC) and additional data will be collected at scheduled follow-up visits (baseline, 6, 12, 24, and 36 months), including clinical, auxological, and biological parameters. Additional metabolic markers, inflammatory and endothelial biomarkers will be assessed. In a subset of patients, carotid intima-media thickness (cIMT) and body fat distribution (via DEXA-scan) will also be measured.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients will be classified into two groups (depending on their treatment as decided by their pediatric endocrinologist): * patients with GHD who receive daily rhGH= rhGH cohort * patients with GHD who receive weekly LAGH= LAGH cohort
| Arm | Type | Receives |
|---|---|---|
| rhGH cohort | Other | Other: metabolic and auxological outcomesPatients with GHD who receive daily rhGH (dose titration according to guidelines i.e. 25-35 micrograms/kg body weight/day) |
| LAGH cohort | Other | Other: metabolic and auxological outcomesPatients with GHD who receive weekly LAGH (dose titration according to guidelines i.e. for somatrogon 0.66 milligrams/kg body weight/week) |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Diagnosed with growth hormone deficiency (GHD)
- Treated with growth hormone (rhGH or LAGH)
Key exclusion criteria (1 listed)
- No exclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| metabolic and auxological outcomesEvaluation over a three-year period following the initiation of treatment with daily recombinant human growth hormone (rhGH) | Other | rhGH cohort |
| metabolic and auxological outcomesEvaluation over a three-year period following the initiation of treatment with weekly long-acting growth hormone (LAGH). | Other | LAGH cohort |
Primary outcome
Auxological evaluation_1
Time frame: 3 years
Primary outcome measures included change in stature (in cm and SDS) over the course of the study.
Auxological evaluation_2
Time frame: 3 years
Primary outcome measures included change in weight (in kgs and SDS) over the course of the study.
Auxological evaluation_3
Time frame: 3 years
Primary outcome measures included change in BMI (in kg/m2) over the course of the study.
Evaluation of the blood pressure
Time frame: 3 years
Measure of the systolic and diastolic blood pressure (in mmHg) with a sphygmomanometer
Evaluation of waist circumference
Time frame: 3 years
Measure of waist circumference (in cm) with a meter
Evaluation of clinical signs of puberty (Tanner stage) and androgenism
Time frame: 3 years
Evaluation of clinical signs of puberty (Tanner stage) and androgenism.
Metabolic evaluation_1
Time frame: 3 years
Evaluation of the change of the metabolic profile using both SOC and non-SOC Blood tests samples. Measurements of fasting glycemia (mg/dl).
Metabolic evaluation_2
Time frame: 3 years
Evaluation of the change of the metabolic profile using both SOC and non-SOC Blood tests samples. Measurements of fasting insulin (pmol/L).
Metabolic evaluation_3
Time frame: 3 years
Evaluation of the change of the metabolic profile using both SOC and non-SOC Blood tests samples. Measurements of hemoglobin A1c in diabetic patients (%).
Metabolic evaluation_4
Time frame: 3 years
Evaluation of the change of the metabolic profile using both SOC and non-SOC Blood tests samples. Measurements of transaminases (UI/L).
Metabolic evaluation_5
Time frame: 3 years
Evaluation of the change of the metabolic profile using both SOC and non-SOC Blood tests samples. Measurements of lipid profile (mg/dL).
Metabolic evaluation_6
Time frame: 3 years
Evaluation of the change of the metabolic profile using both SOC and non-SOC Blood tests samples. Measurements of creatinine (mg/dL).
Metabolic evaluation_7
Time frame: 3 years
Evaluation of the change of the metabolic profile using both SOC and non-SOC Blood tests samples. Measurements of alkaline phosphatase (UI/L).
Metabolic evaluation_8
Time frame: 3 years
Evaluation of the change of the metabolic profile using both SOC and non-SOC Blood tests samples. Measurements of calcium (mmol/L).
Metabolic evaluation_9
Time frame: 3 years
Evaluation of the change of the metabolic profile using both SOC and non-SOC Blood tests samples. Measurements of phosphorus (mmol/L).
Metabolic evaluation_10
Time frame: 3 years
Evaluation of the change of the metabolic profile using both SOC and non-SOC Blood tests samples. Measurements of insulin-like growth factor 1 levels (ng/mL).
Bone markers_1
Time frame: 3 years
Measurements in blood samples of bone markers such as procollagen type 1 N-terminal propeptide (µg/L).
Bone markers_2
Time frame: 3 years
Measurements in blood samples of bone markers such as insulin-like growth factor (ng/mL).
Bone markers_3
Time frame: 3 years
Measurements in blood samples of bone markers such as insulin-like growth factor binding protein (µL/mL).
Endothelial stress and inflammatory markers_1
Time frame: 3 years
Measurements in blood samples of endothelial stress and inflammatory markers such as asymmetric dimethylarginine (µmol/L).
Endothelial stress and inflammatory markers_2
Time frame: 3 years
Measurements in blood samples of endothelial stress and inflammatory markers such as TNF-a (pg/mL).
Endothelial stress and inflammatory markers_3
Time frame: 3 years
Measurements in blood samples of endothelial stress and inflammatory markers such as VEGF (pg/mL).
Endothelial stress and inflammatory markers_4
Time frame: 3 years
Measurements in blood samples of endothelial stress and inflammatory markers such as IL-6 (pg/mL).
Radiological evaluation of cIMT
Time frame: 3 years
Measurements of cIMT (mm) using Doppler ultrasound.
Radiological evaluation of body fat distribution
Time frame: 3 years
Measurements of body fat distribution (g/cm2) using DEXA-Scan.
2 secondary outcomes
comparison with patients under weekly LAGH
Time frame: 3 years
Stratification of the metabolic profile of the patients according to IGF-1 levels
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Micheline Grillet, PhD contact
Philippe Lysy, MD, PhD principal investigator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Questions about this trial
What is this clinical trial studying?
A study testing metabolic and auxological outcomes in people with Growth Hormone Deficiency, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laure Boutsen, MD (+32276441370, laure.boutsen@saintluc.uclouvain.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Auxological evaluation_1 (time frame: 3 years). The study lists 25 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2026.